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Protocol - Eye Drop Use

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Description:

A series of five questions to assess the participants current use of drops for glaucoma, artificial tears or prescription medication for dry eyes, and steroid eye drops.

Specific Instructions:

None

Protocol:

Administration Instructions:

Question 3: There are many manifestations of "dry eye" besides the symptoms in the question, including excess tearing. Most people will be familiar with this condition. They need not have been told by an eye doctor they have this condition. Emphasize "for the past 3 months or longer" when you ask this question. If the participant has occasional episodes of dry eye, it should on average be a complaint at least 4 out of 7 days for the past 3 months or longer. Emphasize "not related to allergy" when using the probe for this question.

Question 4: There are a number of over-the-counter artificial tears which are used for this condition. Visine, taken for allergies, does not qualify as an artificial tear unless specifically prescribed for dry eye. Drops taken for contact lens do not qualify as artificial tears for dry eye. Note that the question requires current (4 out of 7 days) use for 3 months or longer.

1. Is the participant currently taking drops for glaucoma?

0[ ]no

2[ ]yes

8[ ]uncertain

2. What is the name of the glaucoma drops you are using?

2865[ ]Alphagan®

1152[ ]Betagen®

1156[ ]Betopic

2770[ ]CoSopt®

2014[ ]Pilocar®

2298[ ]Timolol

2299[ ]Timoptic®

2437[ ]Xalatan®

[ ]   Other _________________

8001[ ]Unknown

3. For the past 3 months or longer, have you had dry eyes? (foreign body sensation with itching and burning, sandy feeling, NOT related to allergy)

0[ ]no

2[ ]OD

3[ ]OS

4[ ]OU

5[ ]?eye

8[ ]DK

4. Do you currently use artificial tears or prescription medication for dry eyes regularly for 3 months or longer?

0[ ]no

2[ ]yes

8[ ]DK

5. Are you currently using steroid eye drops?

0[ ]no

2[ ]yes

8[ ]DK

Alphagan® and Betagen® are a registered trademarks of Allergan, Inc,; CoSopt® and Timoptic® are registered trademarks of Merck & Co., Inc.; Pilocar® is a registered trademark of Novartis Corporation; Xalatan® is a registered trademark of Pfizer Health AB.

Protocol Name from Source:

Not applicable.

Availability:

Publicly available

Personnel and Training Required

The interviewer must be trained to conduct personal interviews with individuals from the general population. The interviewer must be trained and found to be competent (i.e. tested by an expert) at the completion of personal interviews*.

*There are multiple modes to administer this question (i.e., pencil and paper and computer-assisted interviews).

Equipment Needs

Either a pencil and paper or computer-assisted instrument may be used. If a computer-assisted instrument is used, computer software may be necessary to develop the instrument. The interviewer will require a laptop computer/handheld computer to administer a computer-assisted questionnaire.

Requirements
Requirement CategoryRequired
Major equipment No
Specialized training No
Specialized requirements for biospecimen collection No
Average time of greater than 15 minutes in an unaffected individual No
Mode of Administration

Interviewer-administered questionnaire

Life Stage:

Adult

Participants:

Adults aged 43 to 86 years*

* While this protocol was used in a study of adults aged 43 to 86 years, the Ocular Working Group suggests that the same methodology can be used for individuals aged 18 years or older.

Selection Rationale

The questions suggested have had wide use in long term studies of ocular diseases.

Language

English

Standards
StandardNameIDSource
Common Data Elements (CDE) Person Eye Drops Use Assessment 3007567 CDE Browser
Logical Observation Identifiers Names and Codes (LOINC) Eye drop use proto 62687-9 LOINC
Derived Variables

None

Process and Review

Not applicable.

Source
National Eye Institute, University of Wisconsin, Beaver Dam Eye Study

Beaver Dam V- 20 Year Follow-Up Interview Form

Question numbers: 55-570 [GLAU-DROPS5] (question 1), 55-572 [GLAU-NAME5] (question 2), 56-092 [DRY-EYE5] (question 3), 56-094 [DRY-EYE-RX5] (question 4), and 56-114 [STEROIDROP5] (question 5).

Last revised 2/6/09
General References

Wong TY, Knudtson MD, Klein BE, Klein R, Hubbard LD. (2005). Medication use and retinal vessel diameters. Am J Ophthalmol, 139(2):373-5.

Protocol ID:

110501

Variables:
Export Variables
Variable NameVariable IDVariable DescriptionVersiondbGaP Mapping
PX110501_Currently_Take_Glaucoma_Drops PX110501010000 Is the participant currently taking drops more
for glaucoma? show less
Variable Mapping
PX110501_Currently_Use_Steroid_Eye_Drops PX110501050000 Are you currently using steroid eye drops? Variable Mapping
PX110501_Dry_Eyes_Past_3_Months PX110501030000 For the past 3 months or longer, have you more
had dry eyes? (foreign body sensation with itching and burning, sandy feeling, NOT related to allergy) show less
Variable Mapping
PX110501_Dry_Eye_Artificial_Tears_Prescription_Medication PX110501040000 Do you currently use artificial tears or more
prescription medication for dry eyes regularly for 3 months or longer? show less
Variable Mapping
PX110501_Glaucoma_Drops_Name PX110501020100 What is the name of the glaucoma drops you more
are using? show less
N/A
PX110501_Glaucoma_Drops_Name_Specify PX110501020200 Specify other glaucoma drops you are using. N/A
Ocular
Measure Name:

Eye Drop Use

Release Date:

February 26, 2010

Definition

Questions to determine current and recent eye drop use

Purpose

These questions are to assess use of eye drops in general for those investigators who are interested in use of both prescription and over the counter medications. Use of specific medications may be used to augment information about the burden of specific eye conditions such as glaucoma. Also, some of the medications have systemic effects which may be of interest to an investigator.

Keywords

Ocular, Eye, Eye drops, Artificial tears, Medications, Beaver Dam Eye Study